- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02526953
Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients
February 7, 2021 updated by: Sergey Gordeyev, Blokhin's Russian Cancer Research Center
Randomised Phase III Trial of Chemoradiotherapy With or Without Paclitaxel in Patients With Squamous-cell Anal Cancer
The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
This trial aims to investigate the efficacy of chemoradiotherapy with or without paclitaxel in squamous-cell anal cancer.
This is a prospective multicenter open-label randomized phase III clinical trial.
Patients will be randomized using an online randomization system to receive either standard IMRT with capecitabine and mitomycin or IMRT with capecitabine, mitomycin and paclitaxel.
A stratification will be performed based on T stage, N stage and clinical center.
Doses of capecitabine and mitomycin in experimental group were reduced for better treatment tolerance.
The target accrual is 157 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 15% 3-yr disease-free survival (70% vs 85%), α=0,05, power 80% in the experimental arm.
An interim analysis is planned after 50% of the patients will reach a 3-year followup.
Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging and followup.
Pelvic MRI and histological diagnosis are subject to central review.
Conduction of this study and data collection are controlled by a local institutional board.
Study Type
Interventional
Enrollment (Anticipated)
314
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed consent
- Histologically verified squamous-cell anal cancer
- Stage I-IIIB (Union for International Cancer Control (UICC) TNM classification v7)
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- HIV (Human Immunodeficiency Virus) negative
- Haemoglobin (HGB) > 90 g/L
- Platelet Count (PLT) > 120x10*9/L
- Serum creatinine < 150 µmol/L
- Total bilirubin < 25 µmol/L
Exclusion Criteria:
- inability to obtain informed consent
- distant metastases
- synchronous or metachronous tumors
- previous chemotherapy or radiotherapy
- clinically significant cardiovascular disorders (myocardial infarction < 6 months before visit, stroke < < 6 months before visit, instable angina < 3 months before visit, arrhythmia, uncontrolled hypertension > 160/100 mm hg
- clinically significant neurological disorders
- previous neuropathy 2 or higher
- current infection or heavy systemic disease
- pregnancy, breastfeeding
- ulcerative colitis
- individual intolerance to treatment components
- proven dihydropyrimidine dehydrogenase (DPD) deficiency
- participation in other clinical trials
- psychiatric disorders, which render patient unable to follow instructions or understand his/her condition
- technical inability to perform pelvic MRI
- inability of long-term followup of the patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paclitaxel
Patients will receive intensity-modulated radiotherapy with dose based on T stage.
The planned doses to the primary tumor and pelvis are 52-58 Gy and 44 Gy, respectively.The concurrent chemotherapy regimen will consist of paclitaxel 45 mg/m2 on days 3,10,17,24,31, capecitabine 625 mg/m2 bid on treatment days and mitomycin C 10 g/m2 on day 1.
|
825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
Other Names:
45 mg/m2, IV, weekly during the radiation.
Number of infusions: 5.
Other Names:
625 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
Other Names:
10 mg/m2, IV, on day 1.
Number of infusions: 1.
Other Names:
12 mg/m2, IV, on day 1.
Number of infusions: 1.
Other Names:
Dose: 44 Gy on regional nodes, 52-58 Gy on primary tumor, based on T stage
|
Active Comparator: Standard
Patients will receive intensity-modulated radiotherapy with dose based on T stage.
The planned doses to the primary tumor and pelvis are 52-58 Gy and 44 Gy, respectively.The concurrent chemotherapy regimen will consist of capecitabine 825 mg/m2 bid on treatment days and mitomycin C 12 g/m2 on day 1.
|
825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
Other Names:
625 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
Other Names:
10 mg/m2, IV, on day 1.
Number of infusions: 1.
Other Names:
12 mg/m2, IV, on day 1.
Number of infusions: 1.
Other Names:
Dose: 44 Gy on regional nodes, 52-58 Gy on primary tumor, based on T stage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3-year disease-free survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year overall survival
Time Frame: 3 years
|
3 years
|
|
Complete response at 26 weeks
Time Frame: 26 weeks
|
26 weeks
|
|
3-year colostomy-free survival
Time Frame: 3 years
|
3 years
|
|
3-year cancer-specific survival
Time Frame: 3 years
|
3 years
|
|
Acute toxicity measured according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0
Time Frame: 30 days
|
Toxicity measured according to NCI-CTCAE v.4.0
|
30 days
|
Late toxicity measured according to Radiation Therapy Oncology Group (RTOG) criteria
Time Frame: 3 years
|
Late toxicity measured according to RTOG criteria
|
3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life according to European organization for research and treatment of cancer (EORTC) Quality of Life questionnaire (QLQ)-C30 (v.3) scale
Time Frame: 3 years
|
Change from baseline in quality of life on the EORTC QLQ-C30 (v.3) scale
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Arsen O Rasulov, PhD, N.N.Blokhin Russian Cancer Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
August 15, 2015
First Submitted That Met QC Criteria
August 17, 2015
First Posted (Estimate)
August 18, 2015
Study Record Updates
Last Update Posted (Actual)
February 9, 2021
Last Update Submitted That Met QC Criteria
February 7, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Anus Neoplasms
- Anus Diseases
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Antibiotics, Antineoplastic
- Paclitaxel
- Capecitabine
- Mitomycins
- Mitomycin
Other Study ID Numbers
- SCAC-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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